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510(k) Data Aggregation
K Number
K152270Device Name
Denture base resin
Manufacturer
Date Cleared
2015-11-13
(94 days)
Product Code
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
KOREA ENGINEERING PLASTICS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Smiletone® (denture base resin) is a thermoplastic resin that is intended to be used in fabrication of removable full and partial dental prosthesis, as well as occlusal splints and night guards. The product is based on a compounded mixture of polyamide and pigments.
Device Description
Smiletone® is a thermoplastic material to be used for removable full or partial dental prosthesis. The product is based on a compounded mixture of Polyamide and pigments. Smiletone® is classified as 'Type 3-thermoplastic blank or powder' by EN ISO 20795-1[2013].
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